BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 2932112 · Received January 21, 2013

    Report

    Report Number
    MW5028699
    Event Type
    Injury
    Date Received
    January 21, 2013
    Date of Event
    February 2, 2012
    Report Date
    January 21, 2013
    Product Code
    LZS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD UNDERGONE LASIK SURGERY AT (B)(6) LASER EYE SURGERY CENTERS IN (B)(6) OF 2012. AFTER THE SURGERY MY VISION WAS GREAT DURING THE DAY, BUT I HAVE PROBLEMS WITH NIGHT VISION. I EXPERIENCE STARBURSTS, HALOS, AND GLARE AROUND LIGHTS, AND CONTINUED TO DO SO AT NIGHT. I HAVE BEEN TO THE CENTER FOR CHECK-UPS A WEEK AFTER, MONTH AFTER, 6 MONTHS AFTER, AND THE DOCTOR ASSURED ME THAT THE STARBURSTS, HALOS, AND GLARES WILL EVENTUALLY FADE AWAY, HOWEVER I HAVE NOT NOTICED ANY IMPROVEMENTS SINCE THE SURGERY. ON THE DAY OF THE LAST CHECK-UP, I INSISTED TO THE DOCTOR TO CORRECT THE PROBLEM. THE DOCTOR ASKED ME ONE QUESTION AND THAT WAS IF THE PROBLEMS AFFECTED MY DRIVING AT NIGHT. THE SIDE EFFECTS ARE NOT LIFE THREATENING, BUT THE PROBLEM IS SO SEVERE AND DISRUPTIVE. MY VISION BLEEDS AND SPARKS WITH EVERY LIGHT POST, CAR LIGHT, LIGHT SIGN, AND OTHER BRIGHT LIGHT IN THE AREA. EVEN AFTER I DESCRIBED THE SITUATION TO THE DOCTOR, SHE REPLIED THAT THERE IS NOTHING SHE CAN DO ABOUT IT AND THAT SHE COULD NOT HELP ME FURTHER. SHE STATED THAT 1-2% OF LASIK CANDIDATES EXPERIENCE THESE PROBLEMS. NOTE, I WENT IN 2 TIMES FOR A DIAGNOSTICS AND TESTING A MONTH BEFORE THE SURGERY AND WAS DEEMED A GREAT CANDIDATE FOR LASER CUSTOM LASIK. CUSTOM LASIK CUSTOMVUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28875 LASIK LASIK LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other